# 2026-22369: FDA Refreshes Blood-Safety Guidance Dating Back to the 1980s

2026-22369, Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-11-03, effective 2026-11-03; PRIA reads it as touching household money (as of 2026-11-03).

- Canonical: https://policyrisk.com/federal-register/2026-22369
- As of: 2026-11-03
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-22369
- Title: Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 69258
- Published: 2026-11-03
- Effective: 2026-11-03
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-03

## In one line

FDA Refreshes Blood-Safety Guidance Dating Back to the 1980s

## Summary

The FDA just released new rules to help blood centers better test for hepatitis B, making blood transfusions safer for everyone. Blood banks must follow these updated testing steps starting soon, replacing old guidelines from as far back as the 1980s. These changes aim to catch infections earlier without causing big cost spikes, keeping our blood supply super safe and reliable.

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus." The guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA's recommendations for testing blood and blood components for hepatitis B virus (HBV) to reduce the risk of transfusion-transmitted HBV. The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance titled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen" (July 2025 Draft Guidance). The guidance also supersedes the documents titled "Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)" (December 1987 Memorandum), "FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)" (September 1991 Memorandum), "Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes" (November 2007 Final Guidance), "Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)" (May 2010 Final Guidance), "Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection" (November 2011 Final Guidance), and "Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus" (October 2012 Final Guidance). The guidance supersedes the recommendations specific to HBV in "Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T- Lymphotropic Virus Type I (HTLV- I)" (July 1996 Memorandum).

## Effects PRIA read

- HBsAg Testing Not Required When NAT + anti‑HBc Used: benefit, low. If you operate a blood collection establishment, the FDA recommends that when donations are tested for hepatitis B virus (HBV) DNA by nucleic acid tests (NAT) and for antibody to hepatitis B core antigen (anti‑HBc) using screening tests that FDA has licensed, approved, or cleared and used per the m…
- Source Plasma: HBsAg and HBV NAT Still Required: cost, low. If you collect Source Plasma, the FDA continues to recommend testing Source Plasma donations for both hepatitis B surface antigen (HBsAg) and HBV DNA by nucleic acid tests (NAT) to adequately and appropriately reduce the risk of transfusion‑transmitted HBV. This continuation is stated in the final…

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## Sources
- [2026-22369 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/03/2026-22369/recommendations-for-reducing-the-risk-of-transfusion-transmitted-hepatitis-b-virus-guidance-for)
- [2026-22369 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-03/pdf/2026-22369.pdf)

## Related
- [Previous: 2026-22368, Notice of Availability of the Record of Decision for the Final Supplemental Env…](https://policyrisk.com/federal-register/2026-22368)
- [Next: 2026-22370, Agency Information Collection Activities: Proposed Collection; Comment Request](https://policyrisk.com/federal-register/2026-22370)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-22369 (as of 2026-11-03).